Use of J&J’s single-shot Covid-19 vaccine was paused after the vaccination induced a rare and severe thrombosis with thrombocytopenia
The US Centres for Disease Control (CDC) and Food and Drug Administration (FDA) have announced their decision to resume the vaccinations using Johnson & Johnson (J&J)’s single-shot Covid-19 vaccine.
Use of the J&J single-shot Covid-19 vaccine was paused after it induced a rare and severe type of blood clots (thrombosis) in combination with low platelet counts (thrombocytopenia).
The decision is based on the US CDC Advisory Committee on Immunization Practices (ACIP) recommendation, which follows a rigorous safety review of rare adverse event data.
Medical and scientific teams at the FDA and CDC examined the data to evaluate the risk of adverse reactions involving the cerebral venous sinuses, and other sites in the body.
FDA acting commissioner Janet Woodcock said: “Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work, identifying even these small number of cases.
“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices.
“We have concluded that the known and potential benefits of the Janssen Covid-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older.”
Developed by Janssen, the pharmaceutical company of J&J, the Covid-19 Vaccine has received the FDA EUA in February 2021, for use in people aged 18 years and above.
Following the CDC and FDA’s decision to lift recommended pause, the company has updated the EUA Fact Sheets to include information about the diagnosis and treatment of thrombosis with thrombocytopenia.
The CDC, FDA and American Society of Haematology have also propagated the information regarding identification and management of the rare blood clot, and its treatment.
People who received the J&J Covid-19 vaccine and developed severe headache, chest pain, leg swelling, abdominal pain, blood spots under the skin or bruising are advised to contact their health care provider immediately.
Recently, the European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of the vaccine is positive.
Johnson & Johnson chief scientific officer Paul Stoffels said: “As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable Covid-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere.
“We will collaborate with health authorities around the world to educate healthcare professionals and the public to ensure this very rare event can be identified early and treated effectively.”